Baxter PD Transfer Sets Recalled Due to Chemical Damage Risk
Baxter Healthcare is recalling approximately 58,194 units of its MiniCap Extended Life PD Transfer Sets distributed worldwide because certain cleaning products may damage the sets, causing leaking or cracking.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II FDA medical device recall meets the high-severity criterion for risk-of-harm products where injury has not yet been reported. The hazard—chemical damage causing leaks or cracks—poses potential risk to the functionality of the transfer set.
Plain-English summary
Baxter Healthcare Corporation is recalling approximately 58,194 units of the Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short (REF R5C4483) distributed worldwide.
The recall was initiated because cleaning products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or solvents such as acetone, toluene, xylene, or cyclohexanone may damage the transfer sets, causing them to leak or crack.
All lot numbers of the affected product within expiry are included in this recall.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 58,194
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers within expiry
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 11 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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